Friday, September 21, 2007

Need for Watchdog Citizen Group For Stem-cell Research

The State of Wisconsin needs a state wide, non-profit, non-partisan, consumer and taxpayer based watchdog group to ensure affordable and accessible pharmaceuticals for Wisconsin citizens in the twenty-first century. As thousands of baby boomers are about to enter the health care delivery system one of the major components of their health care is affordable and accessible medication. Our present medication crisis, particularly for our older and low income citizens, will only grow larger in the years ahead.

It seems ironic to me that a state with such progressive and innovative traditions as Wisconsin, and which now presumes to be the preeminent leader in stem-cell research, may become a “Johnny-come-lately” player in the struggle to bring about more affordable and accessible health care to all its citizens. There is a clear need for greater transparency in the relationship between the Wisconsin’s Department of Administration (DOA), the University of Wisconsin (UW), including its affiliate the Wisconsin Alumni Research Foundation (WARF) and its subsidiary, The WiCell Research Institute, and the private biotech commercial interests.

This intermingling and blurring of public with private biotech dollars can best be seen in Wisconsin’s $750 Institutes for Discovery initiative. Public guidelines and procedures should be put in place to allow independent transparency and accountability with regular audits to prevent even a shadow of misconduct.

Without a citizens’ watchdog group, the potential for conflicts of interest, fraud and corruption remains high. Similarly, the risk that consumers’ interests resulting from such research will be ignored also remains high. In reading about this joint public-private venture I have yet to see any substantive safeguards taken to help ensure that Wisconsin taxpayers’ investment will result in more affordable medication or therapy products for its citizens in the days ahead. If we are not careful, the eventual outcome will be what we have right now ---thousands of patients remaining in need and beholden and at the mercy of the pharmaceutical industry. This oversight body would help ensure that no blank checks will go to private companies in the false hope that their will somehow be a freewill trickling down effect to our most needy citizens.

The need for greater transparency in the rapidly growing stem-cell research industry is also important in the light of the most recent subterfuge attempted by a private stem-cell research company in California. Driven by the twin desires to be first and to get rich quick we have seen, first in Japan and now here in our own country, blatant deception and half-truths from stem-sell research companies claiming breakthroughs where none actually existed.

Some experts believe that when stem-cell scientists increasingly choose to either own or heavily invest in their own research companies, both bad science and a greater likelihood for fraud and political corruption results. While such systemic conflicts of interest exist, and episodes of pseudo science persist, the media has remained surprisingly quiet. This fact has left consumers without a voice. The principal mission of a watchdog group would be to ensure that public dollars spent to support private biotech research, including stem-cell research, are accompanied with contractual agreements and policies that will result in more affordable and accessible pharmaceutical products in the future.

This group’s goals would also include:

∑ To study and report back to the public on the size and status of the consumers’ stake in public funding of private biotech research in Wisconsin. This study should make explicit the political and economic arrangements that now exist between government, business, the media and the state’s consumers, and the role that each plays in Wisconsin’s bio-tech industry.

∑ To clarify and make more transparent the relationships that exist between the legislature, DOA, UW, WARF, WiCell Research Institute, and private enterprises, particularly those led by scientists/physician-owned or invested bio-tech research companies.

∑ To track and report the amount of both public and private dollars spent on stem-cell research and on the actions taken to protect the taxpayers’ investment in ensuring more affordable medications. To track and report on all licensing revenues and product royalties.

∑ To help assure that Wisconsin’s bio-tech industry is operating consonant with the very highest business, managerial, professional and medical research standards.

In a recent agreement with WARF and the DOA, Wisconsin waived stem-sell license fees for biotech companies that operate in Wisconsin. Out-of-state companies will continue to pay between $75,000 and $400,000 depending on the company’s size. We need to be concerned that Wisconsin dose not put the interests of private biotech investors, located in or out of Wisconsin, ahead of the best interests of taxpayers and perspective patients.
A portion of the money raised through this licensing of scientific studies and resulting discoveries should be used too make new therapies available to people who can’t afford them.

For example, in exchange for such fee waivers, was there any thought given to requiring firms operating in Wisconsin to agree that any therapy products resulting from their scientific discoveries be sold to Wisconsin’s poorest at a special in-state cost? And for those companies operating out of state, certainly a portion of these licensing revenues should be used to make any new therapies that result from such licensed research more affordable and accessible to all Wisconsin consumers.

Consumer related legislation should be considered that would require any biotech companies licensed by WARF or supported by public dollars to agree to sell products resulting from these discoveries at their lowest price. Such a statute could require that a label on such projects clearly state that this product will receive a discount if sold in Wisconsin. A more general consumer focused statute should be written which would deal with ownership policies and rules for all the scientific discoveries or licensed intellectual properties (IP) supported or subsidized by public funding in the State of Wisconsin.

It is not too early to take action now on this issue. For every month that passes where consumers remain outside the communication loop and absent at the stakeholders’ table, the more the public will remain exposed and beholden to the pharmaceutical industry and the ever increasing likelihood that our medication bills will continue to be priced beyond the reach of many older Americans.

The need for such a group is all the more necessary when we consider that when most citizens are attacked and suffering from a terminally threatening disease, when they are weakest and most vulnerable, they are often also in their greatest financial need. A consumer watchdog group will enable and allow us, while we are strong and healthy, to invest in a worthy and critically important cause. Lets not let Wisconsin citizens when they become ill.